|Número de publicación||US5405355 A|
|Tipo de publicación||Concesión|
|Número de solicitud||US 08/119,711|
|Fecha de publicación||11 Abr 1995|
|Fecha de presentación||10 Sep 1993|
|Fecha de prioridad||10 Sep 1993|
|Número de publicación||08119711, 119711, US 5405355 A, US 5405355A, US-A-5405355, US5405355 A, US5405355A|
|Inventores||Gholam A. Peyman, Stephen A. Updegraff|
|Cesionario original||Vitrophage, Inc.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (7), Otras citas (8), Citada por (34), Clasificaciones (10), Eventos legales (4)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
The invention relates generally to a method of incisional keratotomy, and more particularly to a method of incisional keratotomy that employs a vibrating cutting blade for incising the cornea centrifugally to a maximal predictable depth.
Surgeons performing radial keratotomy incise by utilizing one of two techniques, a centripetal incising technique or a centrifugal incising technique. Each technique has its own advantages and disadvantages.
Centripetal incisions are sometimes preferred because, while using the same blade setting, the centripetal incisions are deeper than centrifugal incisions. Melles, G. R. and Binder, P. S. "Effects of Radial Keratotomy Incision Direction on Wound Depth", Refract Corneal Surg, 6:394, 1990. The differences in incisional depth are due to the uphill vector forces associated with centripetal incisions. Centrifugal incisions are more shallow because of downhill vector forces directed out of the incision.
Centripetal incisions are retraceable and more uniform than centrifugal incisions. Most importantly, the centripetal incisions square off at the optical zone, thus forming a perpendicular architecture at the stopping point of the incision. Centrifugal incisions, on the other hand, round off at the optical zone. The physical characteristics of the cornea such as corneal compressibility, flexibility and intraocular pressure differ with the incisional depth and angle of the two incisional techniques.
Disadvantages of using the centripetal technique are known. A risk of extending centripetal incisions beyond the optical zone exists. Overextending the incision into the optical zone may overcorrect, as well as, reduce vision or cause glare. Such overextension resulting in these injuries may require a corneal transplant. Another disadvantage of the centripetal incision is difficulty in incising straight. Centrifugal incisions, however, are straighter than centripetal incisions.
A blade has been developed, i.e., System DuoTrak, for both centripetal and centrifugal incisions. Casebeer, J. C. and Shapiro, D. R. "Blade designed for improved safety and accuracy in radial keratotomy", J Cataract Refract Surg, 19:314, 1993. In the System DuoTrak, a front diamond blade first incises centrifugally with a full cutting edge. Then a centripetal incision retraces the centrifugal incision by employing a 200 u reverse straight cutting edge at its deepest aspect and a superficial blunt edge at the shallow aspect of the blade. The centrifugal incision is shallow, rounded off at the optical zone, and of irregular depth. The centripetal incision retraces the centrifugal incision correcting these deficits. The dull area of the reverse cutting edge guides the blade back over the centrifugal incision, preventing deviation from the centrifugal incision. The deeper aspect of the reverse cutting edge deeply and uniformly recuts the bottom of the centrifugal incision. When the reverse cutting edge reaches the optical zone, the deep reverse cutting edge stops because of the dull superficial edge of the blade. At this point, the reverse cutting edge squares off the optical zone. The reverse cutting edge will not incise past the optical zone because of the dull aspect of the blade.
Updegraff et al. have described the DuoTrak histology and optical zone structure. Updegraff, S. A., McDonald, M. B. and Benerman, R., "Freeze Fracture Analysis of American, Russian and DuoTrak Incisions", ARVO Abstract, Invest Opthalmol Vis Sci 34 (Suppl): 801, 1993. Updegraff et al. discovered that the centripetal incision made by the reverse cutting edge is irregularly displaced in relation to the centrifugal incision made by the diamond front cutting edge. The centripetal incision irregularly tears the collagen at the base of the first pass incision. Furthermore, the reverse cutting edge does not square off the optical zone. Instead, a portion of midstroma is unincised. Although ramifications of these problems are yet unknown, Updegraff et al. believe they do not duplicate the ideal configuration of the centripetal incision. Furthermore, the DuoTrak incisions may well be less repeatable than centripetal incisions.
This invention is directed to a method of keratotomy comprising centrifugally incising the cornea. The method involves centrifugally incising the cornea with a vibrating cutting blade. By using a vibrating cutting blade, a maximal predictable incisional depth is obtained without irregularly tearing the corneal collagen and with less pressure to overcome compressibility forces of the cornea at the optical zone. This will create a square incision at the optical zone with one limbus directed pass.
Preferably, the blade is a diamond front cutting blade with a reverse cutting edge. This reverse-edge can be used for secondary enhancement procedures thus broadening the application of such a blade. The blade may be vibrated laterally or coaxially as well as ultrasonically. Most importantly, this invention provides a safe method for incising the cornea centrifugally while providing the efficacy of a centripetal incision.
Still other objects and advantages of the present invention will become readily apparent to those skilled in this art from the following detailed description wherein only the preferred embodiment of the invention is shown simply by way of illustration of the best mode contemplated of carrying out this invention. As will be realized, the invention is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the invention. Accordingly, the description is to be regarded as illustrative in nature and not as restrictive.
FIG. 1 illustrates a portion of the cornea of the eye and a vibrating blade used for radial keratotomy according to this invention.
FIG. 1 is an illustration of this invention. A diamond front cutting blade 2 with a 200-215 u reverse cutting edge 9, incises the cornea 3 during radial keratotomy. A vibrating blade handle 4 to which the blade attaches vibrates the blade laterally, coaxially or ultrasonically. Foot plates 5 are attached at the base of the blade handle. These foot plates 5 are parallel to the cornea and prevent too deep an incision by the blade.
The initial entry of the vibrating blade incises the optical zone 6. The vibrating blade overcomes vector forces 7 such as flexibility, compressibility and intraocular pressure forces of the cornea. The vibrating diamond front blade thus incises through the collagen 8 to a maximal predictable depth at the optical zone 6, without tearing the collagen 8 and without blade setting variability or variability due to corneal compression. Blade vibrations or oscillations on the order of about 100 to about 10,000 rate per minute may be employed. The 200-215 u reverse cutting edge 9 also incises the collagen 8 at the optical zone 6, squaring-off the incision 12.
The vibrating blade completes the centrifugal incision as shown by a directional arrow 10. A second enhancement incision as shown by a directional arrow 11 can then be made if the primary procedure leads to undercorrection. The second incision, as the first, does not irregularly tear the collagen, or result in blade setting variability or variability seen with corneal compression. The centrifugal incision eliminates the risk of overextending the incision beyond the optical zone while creating an incision with structural properties most similar to a centripetal incision. The proposed technique would obtain those features of centripetal incisions as shown by Berkeley, R. G., Sanders, D. R. and Piccolo, M. G., "Effect of Incision Direction on Radial Keratotomy Outcome" J Cataract Refract Surg, 17:819-824, 1991, namely, incision predictability and markedly reduced secondary procedures due to undercorrection, yet maintain the safety of a one pass incision toward the limbus. Less pressure exerted on the cornea to create such an incision will also keep intraocular pressure constant and thus prevent depth disparity between incisions in the same cornea.
|Patente citada||Fecha de presentación||Fecha de publicación||Solicitante||Título|
|US4188952 *||12 Sep 1978||19 Feb 1980||Loschilov Vladimir I||Surgical instrument for ultrasonic separation of biological tissue|
|US4619259 *||9 May 1980||28 Oct 1986||Graybill Walter R||Ophthalmic surgery tool|
|US5167725 *||1 Ago 1990||1 Dic 1992||Ultracision, Inc.||Titanium alloy blade coupler coated with nickel-chrome for ultrasonic scalpel|
|US5201747 *||20 Feb 1992||13 Abr 1993||Douglas Mastel||Ophthalmological surgical instrument having a triple edge tip|
|US5222967 *||8 Abr 1992||29 Jun 1993||Magnum Diamond Corporation||Keratorefractive diamond blade and surgical method|
|US5263957 *||4 Oct 1991||23 Nov 1993||Ultracision Inc.||Ultrasonic scalpel blade and methods of application|
|JPH0490751A *||Título no disponible|
|1||Berkeley, R. G., Sanders, D. R. and Piccolo, M. G., "Effect of Incision Direction on Radial Keratotomy Outcome", J Cataract Refract Surg, 17:819-824, 1991.|
|2||*||Berkeley, R. G., Sanders, D. R. and Piccolo, M. G., Effect of Incision Direction on Radial Keratotomy Outcome , J Cataract Refract Surg, 17:819 824, 1991.|
|3||Casebeer, J. C. and Shapiro, D. R. "Blade designed for improved safety and accuracy in radial keratotomy", J Cataract Refract Surg, 19:314, 1993.|
|4||*||Casebeer, J. C. and Shapiro, D. R. Blade designed for improved safety and accuracy in radial keratotomy , J Cataract Refract Surg, 19:314, 1993.|
|5||Melles, G. R. and Binder, P. S. "Effects of Radial Keratotomy Incision Direction on Wound Depth", Refract Corneal Surg, 6:394, 1990.|
|6||*||Melles, G. R. and Binder, P. S. Effects of Radial Keratotomy Incision Direction on Wound Depth , Refract Corneal Surg, 6:394, 1990.|
|7||Updegraff, S. A., McDonald, M. B. and Benerman, R., "Freeze Fracture Analysis of American, Russian and DuoTrak Incisions", ARVO Abstract, Invest Opthalmol Vis Sci 34 (Suppl): 801, 1993.|
|8||*||Updegraff, S. A., McDonald, M. B. and Benerman, R., Freeze Fracture Analysis of American, Russian and DuoTrak Incisions , ARVO Abstract, Invest Opthalmol Vis Sci 34 (Suppl): 801, 1993.|
|Patente citante||Fecha de presentación||Fecha de publicación||Solicitante||Título|
|US5713915 *||15 Nov 1996||3 Feb 1998||Rhein Medical, Inc.||Surgical knife blade|
|US5766198 *||10 Jun 1996||16 Jun 1998||Li; Bing||Surgical knife employing a vacuum to ensure precise depth of incisions|
|US5904678 *||17 Jun 1996||18 May 1999||Lasersight Technologies, Inc.||Multizone, multipass photorefractive keratectomy|
|US5997529 *||27 Oct 1997||7 Dic 1999||Lasersight Technologies, Inc.||Compound astigmatic myopia or hyperopia correction by laser ablation|
|US6007202||22 Oct 1998||28 Dic 1999||Lasersight Technologies, Inc.||Eye illumination system and method|
|US6010497 *||7 Ene 1998||4 Ene 2000||Lasersight Technologies, Inc.||Method and apparatus for controlling scanning of an ablating laser beam|
|US6044069 *||29 Oct 1997||28 Mar 2000||Conexant Systems, Inc.||Power management system for a mobile station|
|US6132424 *||13 Mar 1998||17 Oct 2000||Lasersight Technologies Inc.||Smooth and uniform laser ablation apparatus and method|
|US6193373||27 Dic 1999||27 Feb 2001||Lasersight Technologies, Inc.||Eye illumination system and method|
|US6210169||31 Ene 1997||3 Abr 2001||Lasersight Technologies, Inc.||Device and method for simulating ophthalmic surgery|
|US6231582||18 Dic 1997||15 May 2001||Keravision, Inc.||Corneal pocketing tool|
|US6334683||23 Feb 2001||1 Ene 2002||Lasersight Technologies, Inc.||Eye illumination system and method|
|US6409718||3 Feb 1998||25 Jun 2002||Lasersight Technologies, Inc.||Device and method for correcting astigmatism by laser ablation|
|US6450641||9 Abr 2001||17 Sep 2002||Lasersight Technologies, Inc.||Method of corneal analysis using a checkered placido apparatus|
|US6497701||30 Abr 1999||24 Dic 2002||Visx, Incorporated||Method and system for ablating surfaces with partially overlapping craters having consistent curvature|
|US6540760||19 Jun 2001||1 Abr 2003||Oasis Medical, Inc.||Cutting blade and cutting blade assembly|
|US6554840 *||28 Feb 2001||29 Abr 2003||Mani, Inc.||Medical scalpel|
|US6716210||6 Abr 2001||6 Abr 2004||Lasersight Technologies, Inc.||Refractive surgical laser apparatus and method|
|US7153316||9 Nov 2001||26 Dic 2006||Mcdonald Marguerite B||Surgical instruments and method for corneal reformation|
|US7780689||23 Mar 2004||24 Ago 2010||Technolas Perfect Vision Gmbh||Bar-link drive system for a microkeratome|
|US20030144678 *||31 Ene 2002||31 Jul 2003||Hellenkamp Johann F.||Automatic surgical device and control assembly for cutting a cornea|
|US20040236358 *||23 Mar 2004||25 Nov 2004||Barrile-Josephson Craig A.||Bar-link drive system for a microkeratome|
|US20050049621 *||1 Jul 2004||3 Mar 2005||Vladimir Feingold||Intracorneal lens placement method and apparatus|
|US20060271026 *||3 May 2006||30 Nov 2006||Silvestrini Thomas A||Method and apparatus for aligning a mask with the visual axis of an eye|
|US20070244496 *||23 Ene 2007||18 Oct 2007||Hellenkamp Johann F||Automatic surgical device and control assembly for cutting a cornea|
|US20100211089 *||28 Jul 2008||19 Ago 2010||Karin Tomalla||Cutting Device for a Curved Corneal Channel|
|USRE37304||29 Jul 1999||31 Jul 2001||Rhein Medical, Inc.||Surgical knife blade|
|USRE37504||27 May 1998||8 Ene 2002||Lasersight Technologies, Inc.||Ophthalmic surgery method using non-contact scanning laser|
|DE19604156A1 *||6 Feb 1996||7 Ago 1997||Boehringer Mannheim Gmbh||Schneidvorrichtung für Haut zur schmerzarmen Entnahme kleiner Blutmengen|
|EP1525865A2 *||7 Nov 2002||27 Abr 2005||McDonald, Marguerite B.||Surgical instruments and method for corneal reformation|
|EP1525865A3 *||7 Nov 2002||4 May 2005||McDonald, Marguerite B.||Surgical instruments and method for corneal reformation|
|WO1999030656A1 *||16 Dic 1998||24 Jun 1999||Keravision, Inc.||Corneal pocketing tool|
|WO2006007545A3 *||1 Jul 2005||14 Jun 2007||Biovision Ag||Intracorneal lens placement method and apparatus|
|WO2009013023A1 *||28 Jul 2008||29 Ene 2009||Acri. Tec Gmbh||Cutting device for a curved corneal channel|
|Clasificación de EE.UU.||606/166, 606/169|
|Clasificación internacional||A61B17/32, A61F9/013, A61B19/00|
|Clasificación cooperativa||A61F9/0133, A61B17/320068, A61B2090/036|
|Clasificación europea||A61B17/32U, A61F9/013K|
|10 Sep 1993||AS||Assignment|
Owner name: VITROPHAGE, INC., ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PEYMAN, GHOLAM A.;UPDEGRAFF, STEPHEN A.;REEL/FRAME:006692/0545;SIGNING DATES FROM 19930908 TO 19930909
|3 Nov 1998||REMI||Maintenance fee reminder mailed|
|11 Abr 1999||LAPS||Lapse for failure to pay maintenance fees|
|10 Ago 1999||FP||Expired due to failure to pay maintenance fee|
Effective date: 19990411